Workflow
URGN Stock News: Robbins LLP Reminds UroGen Pharma Ltd. Investors of the Pending Lead Plaintiff Deadline in the URGN Class Action – Contact Robbins LLP Before July 28 for Information
UroGen PharmaUroGen Pharma(US:URGN) GlobeNewswire News Room·2025-07-01 00:34

Core Viewpoint - A class action has been filed against UroGen Pharma Ltd. for allegedly failing to conduct a proper trial for its lead drug candidate, UGN-102, which is intended to treat low-grade intermediate risk non-muscle invasive bladder cancer [1][2]. Group 1: Allegations and FDA Concerns - The complaint alleges that UroGen submitted a rolling new drug application (NDA) for UGN-102 on August 14, 2024 [2]. - On May 16, 2025, the FDA expressed doubts about the sufficiency of the submitted data for UGN-102's effectiveness, highlighting the lack of a concurrent control arm in the ENVISION study [3]. - The FDA had previously recommended a randomized trial design to UroGen multiple times, which the company did not follow [3]. Group 2: Stock Price Impact - Following the FDA's concerns, UroGen's stock price dropped by $2.54, or 25.8%, closing at $7.31 per share on May 16, 2025 [3]. - After the Oncological Drugs Advisory Committee voted against the approval of UGN-102 on May 21, 2025, the stock fell by $3.37, or 44.7%, closing at $4.17 per share [4]. Group 3: Class Action Participation - Shareholders may be eligible to participate in the class action against UroGen, with a deadline to file for lead plaintiff status by July 28, 2025 [6]. - The lead plaintiff will represent other class members in directing the litigation, but participation is not required to be eligible for recovery [6].